The tariff classification of AZD9668 Tosylate in bulk from England

N081364 October 27, 2009 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2933.39.4100 Ms. Zenaida Rodriguez IPR Pharmaceuticals, Inc. P.O. Box 1624 Canóvanas, PR 00729-1624 RE: The tariff classification of AZD9668 Tosylate in bulk from England Dear Ms. Rodriguez: In your letter dated October 20, 2009, you requested a tariff classification ruling. The subject product, AZD9668 Tosylate, is a Neutrophil Elastase Inhibitor (NEI) being developed as a novel oral treatment for Chronic Obstructive Pulmonary Disease (COPD). It is presently in FDA Phase IIb dose range finding clinical trials to evaluate the efficacy and safety of oral administration at three dose levels to patients with COPD on treatment with Tiotropium. Pursuant to the General Notice entitled "Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research," published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for the AZD9668 Tosylate in bulk form will be 2933.39.4100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other." The rate of duty will be 6.5 percent ad valorem. At the present time, the subject product is not listed in the Pharmaceutical Appendix to the Tariff Schedule. General Note 13, HTS noted. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division